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NCT Number: NCT07132671

MRI-guided Brachytherapy and Salvage SBRT Program

Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy

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Key information

About this study

The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.

  • Pathological confirmation is advised in all cases but it is not mandatory .
  • Patients with any of the following were not considered eligible:
  • Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
  • Distant Metastases
  • Isolated nodal relapses
  • Prior Irradiation to the IPBR area
  • Multicentric IPBRs
  • Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
  • No prior radiation therapy to the target areas;
  • Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
  • WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
  • Ability to undergo MRI scanning.

Treatment and study plan

Brachytherapy and MR-Guided SBRT

Radiation

HDR Brachytherapy followed by MR-guided SBRT

Primary outcomes

  1. Biochemical control

    Time frame: 5-year

    To achieve 5-year biochemical control rate in 85% of the patients.

  2. Adverse Events

    Time frame: 5-year

    To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.

Secondary outcomes

  1. QOL

    Time frame: From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter

    Determination of QOL with the EORTC QLQ-PR25

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Ramos Aguirre, M.S.

CONTACT

[email protected]

+34948255400 ext. 2772

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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